# FDA 483 - Newton Laboratories, Inc. - March 30, 2018

Source: https://www.keypedia.com/records/483/newton-laboratories-inc/f51a3f85-7883-462e-8a07-3529d5dc7cdd

> FDA 483 for Newton Laboratories, Inc. on March 30, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Newton Laboratories, Inc.
- Inspection Date: 2018-03-30
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Newton Laboratories Inc., a homeopathic drug manufacturer in Conyers, GA, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies across multiple areas, including process validation, OOS/OOT investigations, quality unit responsibilities, complaint handling, annual product reviews, batch records, cleaning validation, and distribution records. Many of these issues indicate a systemic lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2021-09-17](https://www.keypedia.com/records/483/newton-laboratories-inc/d1a4aea2-af5d-40ea-88f9-3e3ab729ca09)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-l-cook/294a8276-4e31-4d9f-8f2d-6c8f08cefd06)
- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/newton-laboratories-inc/61762181-8a34-4b74-8023-1be775d74406

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7